Antibiotics after gallbladder surgery may be unnecessary
NCT ID NCT01015417
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at whether giving antibiotics after gallbladder removal surgery helps prevent infections in people with mild to moderate gallbladder inflammation. Over 400 adults took part, receiving either antibiotics or no medication after surgery. The goal was to see if antibiotics reduce surgical site or other infections within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amoxicillin clavulanic acid (Augmentin)
- What this could lead to
- If successful, this could show that antibiotics after gallbladder surgery are not needed for mild to moderate cases, reducing side effects and antibiotic resistance.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to severe cases or patients with complications. The benefit of antibiotics may be small or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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414 people
The number who actually took part.
- Start date
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May 2010
- Finished
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Nov 2012
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder) * Requiring early cholecystectomy (progression of symptoms \<5 days * In an adult patient (\>18 years) * For each patient included the consent form must have been read, understood and signed. Exclusion Criteria: * Severe acute cholecystitis (with organ dysfunction) * Acalculous cholecystitis * Biliary peritonitis * Abscess perivesicular * Cholangitis * Acute Pancreatitis * Septic shock * Stone of bile duct * Physical or mental state does not allow participation in the study * Contraindication to surgery * Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy \<48 hours * Suspected pre-or intraoperative cancer of the gallbladder * Pregnancy or breastfeeding * Treatment course with methotrexate, imidazole * Known history of allergy to Augmentin ®
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hopitalier Général
Grenoble, Auvergne-Rhône-Alpes, 38700, France
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Centre Hospitalier
Longjumeau, Ile de Rance, 91161, France
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Centre Hospitalier C.H.A.M.
Rang-du-Fliers, Hauts-de-France, 62180, France
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Centre Hospitalier Cochin
Paris, Île-de-France Region, 75679, France
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Centre Hospitalier Côte e Nacre
Caen, Basse Normandie, 14033, France
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Centre Hospitalier Dupuytren
Limoges, Limousin, 87042, France
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Centre Hospitalier Haut-Lévêque
Bordeaux, Aquitaine, 33604, France
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Centre Hospitalier Jean-Verdier
Bondy, Île-de-France Region, 93143, France
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Centre Hospitalier Louis Mourier
Colombes, Île-de-France Region, 92700, France
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Centre Hospitalier Timone
Marseille, Province-Alpes Côte d'Azur, 13000, France
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Centre Hospitalier de Saint-Germain en Laye
Poissy, Île-de-France Region, 78303, France
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Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire
Strasbourg, Alsace, 67098, France
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Centre hospitalier Lariboisière
Paris, Île-de-France Region, 75475, France
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Centre hospitalier Universitaire
Angers, Pays de la Loire Region, 49933, France
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Chirurgie Viscérale et Digestive
Rouen, Seine Maritime, 76031, France
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Chirurgie viscérale et urologique Centre Hospitalier
Beauvais, Oise, 60021, France
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Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire
Besançon, Doubs, 25030, France
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Service de Chirurgie Digestive et Viscérale
Paris, Île-de-France Region, 75020, France
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Service de Chirurgie Digetsive Centre Hopsitalier Universitaire
Montpellier, Hérault, 34000, France
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Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire
Clermont-Ferrand, Auvergne, 63003, France
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Service de Chirurgie Viscérale et Digestive
Amiens, Picardie, 80054, France